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. 2019 Nov 5;2019(11):CD007647. doi: 10.1002/14651858.CD007647.pub2

Summary of findings 2. Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs.

Community health educational one‐to‐one and group and both counselling (subgroup) compared to control in LMICs
Patient or population: developing countries
 Setting: low‐middle‐income countries, community
 Intervention: community health educational one‐to‐one and group and both counselling (subgroup)
 Comparison: control
Outcomes Relative effect
 (95% CI) № of participants
 (studies) Certainty of the evidence
 (GRADE) Comments
Neonatal mortality ‐ One‐to‐one counselling RR 0.92
 (0.71 to 1.20) 105,735
 (8 RCTs) ⊕⊝⊝⊝
 Very lowa,b,c Not all confidence intervals overlap, and there is some inconsistency in the direction of effect. However the study with the greatest confidence interval reported weights of only 0.2%. This was further downgraded by 1 as the confidence interval includes both important benefit or harm and no effect. Most studies had concerns in areas of bias that may have affected the outcome; however those with high risk of performance bias should not have impacted the outcome of neonatal mortality
Neonatal mortality ‐ Group counselling RR 0.83
 (0.74 to 0.92) 211,164
 (12 RCTs) ⊕⊕⊝⊝
 Lowa,b Around half of the studies raised concerns in areas of bias that may impact the direction of effect; therefore this was downgraded by one level. Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Neonatal mortality ‐ Both group and one‐to‐one counselling RR 0.90
 (0.76 to 1.06) 236,212
 (6 RCTs) ⊕⊕⊕⊝
 Moderateb Not all confidence intervals from the studies overlap; there is also inconsistency in direction across studies
Early neonatal mortality ‐ Group counselling RR 0.70
 (0.61 to 0.80) 122,151
 (9 RCTs) ⊕⊕⊝⊝
 Lowa,b There was a combination of high and unclear risk of bias regarding blinding; this can be attributed mainly to the cluster‐randomised design. The study with the greatest risk of bias concerns had the smallest weighting. Most studies are consistent in the direction of effect; however not all confidence intervals overlap
Early neonatal mortality ‐ One‐to‐one counselling RR 1.30
 (1.01 to 1.67) 18,747
 (1 RCT) ⊕⊕⊝⊝
 Lowa,c There was high risk of bias for selection; however this was a cluster‐randomised trial with a large confidence interval
Early neonatal mortality ‐ Both one‐to‐one and group counselling RR 0.78
 (0.65 to 0.93) 180,690
 (5 RCTs) ⊕⊕⊕⊝
 Moderateb There was considerable heterogeneity (I² = 85%), and not all confidence intervals overlapped
Late neonatal mortality ‐ Group counselling RR 0.50
 (0.31 to 0.81) 118,239
 (7 RCTs) ⊕⊝⊝⊝
 Very lowa,b,c High risk of bias was present for blinding across studies; however these were cluster‐randomised trials, and this is justifiable. There was considerable heterogeneity (I² = 91%), and all studies are consistent in their direction; however not all of them overlap. The confidence interval is wide; however the sample size is sufficient
Late neonatal mortality ‐ Both group and one‐to‐one counselling RR 0.72
 (0.57 to 0.91) 68,404
 (4 RCTs) ⊕⊕⊕⊝
 Moderatec Confidence interval is wide
Perinatal mortality ‐ One‐to‐one counselling RR 0.88
 (0.57 to 1.34) 23,829
 (2 RCTs) ⊕⊝⊝⊝
 Very lowa,b,c One of the studies that had greater weighting had considerable risk of bias that may impact the direction of effect
Confidence intervals do not overlap, and the direction of effect is inconsistent
Confidence interval include both important benefit or harm and no effect
Perinatal mortality ‐ Group counselling RR 0.85
 (0.77 to 0.94) 156,505
 (8 RCTs) ⊕⊕⊝⊝
 Lowa,b The 2 heaviest weighted studies have concerns regarding selection bias
Most confidence intervals overlap, and only 1 study (that has less weighting) is going in the opposite direction of effect
Perinatal mortality ‐ Both group and one‐to‐one counselling RR 0.78
 (0.67 to 0.90) 82,279
 (5 RCTs) ⊕⊕⊝⊝
 Lowb,c The confidence interval is wide; however the sample size is sufficient. Most confidence intervals overlap; however 1 of the studies is inconsistent in its direction of effect (although it is weighted the least)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
 
 CI: confidence interval; LMICs: low‐ and middle‐income countries; RCT: randomised controlled trial; RR: risk ratio.
GRADE Working Group grades of evidence.High certainty: we are very confident that the true effect lies close to that of the estimate of the effect.
 Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
 Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
 Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect.

aRisk of bias.

bInconsistency.

cImprecision.